Protocol Development

Protocol Development

The Office for Clinical Research is committed to supporting Cancer Center clinical investigators in the development and implementation of investigator-initiated clinical trials. The OCR assists investigators at any stage in their trials by offering specialized assistance in the following:

  • Development and writing of clinical trial protocols in compliance with regulatory authorities
  • Assistance with submissions to PRC and IRB-HSR
  • Preparation of additional documentation (i.e. FDA submissions, Informed Consents and Investigators Brochures)
  • Educate study staff to assist study start-up
  • Individualized support 


To discuss your investigator-initiated trial needs, please contact our Protocol Development Specialist.

Additional Resources:

NCI/CTEP Protocol Guidance

Protocol Guidance Document